BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHILLIPS AGM

    MDR report key: 532386 · Received June 2, 2004

    Report

    Report Number
    532386
    Event Type
    Other
    Date Received
    June 2, 2004
    Date of Event
    May 14, 2004
    Report Date
    May 24, 2004
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    BSZ
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNABLE TO MAINTAIN SA O2 (OXYGEN SATURATION) WITHOUT ASSISTANCE. AGM (ANESTHESIA GAS MACHINE) READING 1.6 INHALATION/1.2 EXHALATIONS WITH NO ANESTHETIC AGENTS BEING DELIVERED. 100% O2 VIA MASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILLIPS AGM ANESTHESIA MACHINE AND GAS ANALYZER BSZ PHILIPS MEDICAL SYSTEMS, INC. M1026A *
    2 MODULUS II VENTILATOR CBK DATEX-OHMEDA, INC. MODULUS 2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other